Using spirometry to manage IgG therapy in patients with Common Variable Immunodeficiency and airway disease

A Prospective Study of the Utility of Spirometry to Identify and Manage Immunoglobulin Replacement Dosage in Primary Antibody Deficiency in Patients With Potentially Reversible Airway Disease

This study is testing if increasing the dose of immunoglobulin therapy can help improve lung function in people with Common Variable Immunodeficiency who have mild to moderate airway problems.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT05193552 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the role of spirometry in managing immunoglobulin therapy for patients with Common Variable Immunodeficiency (CVID) who exhibit mild to moderate airway obstruction. The study will enroll 22 participants currently receiving stable immunoglobulin replacement therapy and assess their lung function using spirometry. Half of the participants will continue their current treatment while the other half will receive an increased dose of therapy over six months to evaluate improvements in lung function. The goal is to determine if higher doses of immunoglobulin can enhance lung function in patients with specific spirometry results.

Who should consider this trial

Good fit: Ideal candidates are adults with Common Variable Immunodeficiency on stable immunoglobulin replacement therapy who have specific spirometry results indicating mild to moderate obstruction.

Not a fit: Patients under 21, those unable to perform spirometry, or with certain other health conditions will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved lung function and reduced pulmonary infections in patients with CVID.

How similar studies have performed: While there is existing literature suggesting benefits of increased immunoglobulin therapy, this specific approach using spirometry for titration is novel and has not been previously published.

Eligibility criteria

Inclusion Criteria:

1. Patients who meet criteria for common variable immune deficiency (CVID) who are on stable IGRT for at least 3 months and who have an FEF25-75% between 50% and 80% of predicted.
2. Patients who are already on Hizentra will be preferred.

Exclusion Criteria:

1. Age \<21 or cannot perform spirometry.
2. Smokers with 20 pack years or more, and active smokers will not be included among the study subjects, but will be considered separately as an ancillary study.
3. Patients with specific antigen-specific antibody deficiencies or X-linked agammaglobulinemia on IGRT will not be included among the 20 study subjects, but will be considered separately in ancillary studies.
4. Patients with heart failure, TB, bronchiolitis, or lymphangioleiomyomatosis.

Where this trial is running

Birmingham, Alabama

• Community Health 20 — Birmingham, Alabama, United States (Recruiting)

Study contacts

• Principal investigator: Harry Schroeder, MD/PhD — University of Alabama at Birmingham
• Study coordinator: Leigh Powell

Conditions Common Variable Immunodeficiency